NCT07241819

Ivonescimab Monotherapy or in Combination With Chemotherapy as Neoadjuvant/Adjuvant Therapy for Resectable Non-small Cell Lung Cancer

Evaluate the Efficacy and Safety of Ivonescimab Monotherapy or in Combination With Chemotherapy as Neoadjuvant/Adjuvant Therapy for Resectable Non-small Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, II Phase clinical trial designed to evaluate the efficacy and safety of ivonescimab as monotherapy or in combination with platinum-based chemotherapy in the perioperative treatment of resectable non-small cell lung cancer (NSCLC). Patients are stratified by PD-L1 expression level (TPS ≥50% vs. \<50%) and randomized in a 2:1 ratio to differentiated neoadjuvant treatment arms: PD-L1≥50% subgroup: Ivonescimab monotherapy (4 cycles) vs. ivonescimab + platinum-based chemotherapy (4 cycles); PD-L1\<50% subgroup: Ivonescimab + 1 cycle of chemotherapy followed by 3 cycles of monotherapy vs. ivonescimab + platinum-based chemotherapy (4 cycles). All patients subsequently receive 13 cycles of ivonescimab as adjuvant maintenance therapy postoperatively. As the first study to explore a PD-L1-directed chemotherapy de-escalation strategy, this trial aims to reduce treatment toxicity while maintaining efficacy, thereby providing a novel personalized precision therapy pathway for resectable NSCLC.

Conditions

• II-IIIB (T3N2) Resectable Non-small Cell Lung Cancer
• Perioperative

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Ivonescimab/surgery	Ivonescimab monotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)
COMBINATION_PRODUCT	Ivonescimab/chemotherapy/surgery	Ivonescimab + 1cycle of platinum-based chemotherapy followed by 3 cycles of Ivonescimab monotherapy→surgery→Ivonescimab(13 cycles)
COMBINATION_PRODUCT	Ivonescimab/chemotherapy/surgery	Ivonescimab + platinum-based chemotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)
COMBINATION_PRODUCT	Ivonescimab/chemotherapy/surgery	Ivonescimab + platinum-based chemotherapy (4 cycles)→surgery→Ivonescimab(13 cycles)

Timeline

• Start date: 2025-11-30
• Primary completion: 2027-11-30
• Completion: 2028-11-30
• First posted: 2025-11-21
• Last updated: 2025-11-21